Study Evaluating the Efficacy of the myDIET Software Tool in the Nutritional Management of Patients With Localized and Resectable Gastric or Esogastric Junction Cancer.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: myDIET software tool.
- Who it may be relevant to
- Registry conditions: Gastric Cancer, Oesogastric Junction Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Efficacy of the myDIET Software Tool in the Nutritional Management of Patients With Localized and Resectable Gastric or Esogastric Junction Cancer.
Overview
This is a prospective, single-center, single-arm Phase II study evaluating the efficacy of the myDIET software tool in the nutritional management of patients with localized and resectable esogastric junction cancer.
Detailed description
Gastric cancer is the 3rd leading cause of cancer mortality worldwide, with a 5-year survival rate of less than 30%. In localised gastric cancer (GC) or cancer of the oesogastric junction (OGJ), the standard treatment consists of gastrectomy and peri-operative FLOT-based chemotherapy (5FU, Leucovorin, Oxaliplatin, Taxotere). However, up to 51% of patients have post-operative complications, and only 60% can benefit from post-operative chemotherapy (at least one course) initiated within 12 weeks of surgery, while 46% receive the full theoretical regimen.
An incomplete adjuvant chemotherapy regimen drastically reduces post-operative prognosis. Undernutrition and sarcopenia increase the occurrence of post-operative complications, length of stay and post-operative readmissions. Undernutrition is an independent risk factor for failure and/or incomplete adjuvant chemotherapy, with an impact on progression-free survival and overall survival. There is a high prevalence of undernutrition in patients with GC/OGJ, estimated at 53-60%, and the proportion of undernourished patients increases significantly postoperatively compared with preoperatively.
Preoperative nutrition and physical activity in sarcopenic patients has been shown to reduce postoperative complications. Early multimodal management, combining nutrition, adapted physical activity and neoadjuvant chemotherapy, is therefore recommended and essential in the perioperative situation. To optimise the nutritional management of patients with operable gastric or oesogastric junction cancer, the CLB teams have developed a computer interface (MyDIET) linked to the myCLB patient portal. This provides semi-personalised monitoring based on self-questionnaires designed to assess and educate patients or their carers about nutritional issues from the outset of oncology treatment, and to prevent the onset or worsening of undernutrition.
For this reason, the sponsor proposes an exploratory study to assess the efficacy of the myDIET digital tool in increasing the proportion of patients with localised CG/OGJ initially treated with neo-adjuvant chemotherapy and who undergo surgery and are able to receive adjuvant chemotherapy within 8 weeks post-operatively.
Interventions
- Other myDIET software tool
The tool is based on self-questionnaires completed by the patient. They are mainly filled in using visual analogue scales (from 0-10) or grades of symptoms/toxicities (Grades 0 to 4), based on the CTCAE V5. These scales will cover the following themes: food intake, weight changes, digestive symptoms, taste disorders, pain and fatigue. The system will be able to monitor data changes and the response given will be adapted according to the severity of symptoms: * No signs of seriousness: general p
Primary outcome measures
- Proportion of patients starting adjuvant treatment within 2 months [Time frame: 2 months after surgery]
Secondary outcome measures (12)
- Adherence to the tool [Time frame: From inclusion and up to 6 months after surgery]
- Number of supportive care and emergency consultations initiated by the caregiver [Time frame: From inclusion and up to 6 months after surgery]
- Proportion of patients with malnutrition [Time frame: From inclusion and up to 6 months after surgery]
- Evolution of body composition in L3 section (volumes) [Time frame: From inclusion and up to 6 months after surgery]
- Evolution of body composition in L3 section (indexes) [Time frame: From inclusion and up to 6 months after surgery]
- Evolution of resting energy expenditure [Time frame: From inclusion and up to 1 month after surgery]
- Proportion of patient covering theoretical nutritional requirement >= 30kcal/kg/day [Time frame: From inclusion and up to 6 months after surgery]
- Comparison between theoretical nutritional requirement and measurement of basal metabolic rate using indirect calorimetry [Time frame: From inclusion and up to 6 months after surgery]
- Weight changes [Time frame: From inclusion and up to 6 months after surgery]
- Brachial circumference changes [Time frame: From inclusion and up to 6 months after surgery]
- Triceps skin fold changes [Time frame: From inclusion and up to 6 months after surgery]
- Initiation time for post-operative treatment [Time frame: From surgery to date of post operative treatment initiation assessed up to 6 months after surgery]
Eligibility criteria
Inclusion criteria
- Patient 18 years of age or older at date of signing informed consent to participate;
- Histologically proven diagnosis of gastric adenocarcinoma or OGJ;
- Localized, resectable disease;
- Patients with an indication for perioperative chemotherapy and/or immunotherapy validated in multidisciplinary consultation meeting, with a scheduled surgery date at least 1 month after enrolment;
- Performance status (ECOG): 0-2;
- Membership of a social security scheme;
- Signed informed consent to participate.
Exclusion criteria
- Other associated solid cancer or haemopathy;
- Presence of severe comorbidity (Charlson index > 9)
- Presence of unbalanced dysthyroidism;
- History of gastric, duodenal or esophageal surgery;
- Inability to comply with study requirements, including :
- Impossibility for the patient or his/her caregiver to connect to myDIET;
- Difficulty in understanding the written French language;
- Psychological incapacity (e.g. excessive vulnerability, psychiatric disorder) or physical incapacity (e.g. physical/motor disability);
- Patient under guardianship, curatorship or safeguard of justice;
- Patients already participating in a clinical trial or interventional study likely to interfere with the evaluation of the primary endpoint.
- Pregnant or breast-feeding patient.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
France · 1 center
- Centre Léon Berard — Lyon
Identifiers
NCT: NCT06385691 · ET22-145